The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 5, 2016
May 1, 2016
1 year
May 3, 2016
May 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA
24 hours postop
Study Arms (2)
Lidocaine
ACTIVE COMPARATORPatients will receive Lidocaine drip during spine surgery
Placebo
PLACEBO COMPARATORPatients will receive placebo during spine surgery
Interventions
Eligibility Criteria
You may qualify if:
- spine surgery with general anesthesia
You may not qualify if:
- lidocaine allergy
- hepatic disease
- dementia or cognitive decline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, 5262100, Israel
Related Links
- Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial.
- Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study.
- Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 5, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
May 5, 2016
Record last verified: 2016-05